Despite four successive lockdowns, COVID-19 cases and deaths kept mounting day by day till mid-September last year. Since January 16, 2021, we have two vaccines under emergency use authorisation, now being given to all those aged 45 and above. More than 100 million doses have been administered so far. Such a gigantic mission entails a greater responsibility on the part of the government to watch out for unintended harm or collateral damage from the vaccine. There are committees of technical experts to monitor ‘adverse events following immunisation’ (AEFI) and there are established mechanisms by the World Health Organization (WHO) to monitor, investigate and report such events.
No thorough investigation
The common man relies on a responsible and responsive government to safeguard him against any vaccine-induced harm, including an unfortunate death. Although 180 deaths out of the 617 severe and serious adverse events up to end March were supposed to have followed COVID-19 vaccination, no case of serious AEFI, including death, has been attributed to the COVID-19 vaccine. ‘There is no link to vaccination’ is the quick response by authorities even before a systematic investigation, including a post-mortem examination, is completed. A line list of less than 15 deaths are visible to the public on the Ministry of Health website. The time of death or the period of gap between the vaccination and death is not mentioned. Some deaths are not even fully documented. Knowing the time line pattern of deaths after vaccination is important.
Media reports indicate that many deaths after taking AstraZeneca’s Covishield occurred due to cardiac arrest, cerebral venous thrombosis, and stroke. Deaths in Germany and Norway were also due to clots or thrombus formation following a jab of AstraZeneca’s vaccine. Ireland, Denmark and Iceland are among the countries which have suspended AstraZeneca’s vaccine .
In India, Dr. N.K. Arora, Adviser, National AEFI Committee, and member of the COVID-19 National Task Force, said that “in 38 out of 71 post-mortem reports received so far, a causal link to the vaccine has not been established. All the events so far are coincidental”. That means that many cardiac arrests and strokes would have occurred in any case in the population without vaccination. Mere coincidence is not an easy verdict to pronounce unless investigations are thoroughly completed.
Only a histopathological examination of tissues after autopsy can establish the diffused thromboembolic phenomena and multiple infarcts of the heart, lungs, and brain, which is different from the single or couple of clots that occur in heart attacks and strokes normally. There is no evidence of such a thorough investigation being done at the sub-district level in India.
When thousands die due to various illnesses and accidents daily, a bus accident killing 20 people should not make news, but it does. So also nine deaths after 20 million people getting the vaccine in Europe and the U.K. should not cause concern if it is not associated with the vaccine. But if there is an association, the death becomes preventable. That is why the deaths became a serious issue for the European Medicines Agency (EMA). Severe and fatal coagulopathies occurred in young individuals following vaccination, leading more than 15 countries to suspend their AstraZeneca vaccination programme.
After a detailed review and allowing AstraZeneca’s vaccine to be continued, the EMA stated that “the benefits of the vaccine in combating the still widespread threat of COVID-19 (which itself results in clotting problems and may be fatal) continue to outweigh the risk of side effects”. It admitted that the “vaccine may be associated with very rare cases of blood clots associated with thrombocytopenia”.
Several doctors of global professional standing signed a protest letter, endorsed by many others, to Emer Cooke, Executive Director of the EMA, against this decision. They wrote: “While we recognise that these occurrences might, every one of them, have been unfortunate coincidences, we are concerned that there has been and there continues to be inadequate scrutiny of the possible causes of illness or death under these circumstances, and especially so in the absence of post-mortem examinations. In particular, we question whether cardinal issues regarding the safety of the vaccines were adequately addressed prior to their approval by the European Medicines Agency.”
They assume that the vaccines, which are gene-based agents, will “remain entrapped in the circulation and be taken up by endothelial cells, particularly at sites of slow blood flow, i.e., in small vessels and capillaries... It must be expected that endothelial damage with subsequent triggering of blood coagulation via platelet activation will ensue at countless sites throughout the body.”
They postulate that will lead to “a drop in platelet counts, appearance of D-dimers (bio-marker for disease severity) in the blood, and to myriad ischemic lesions throughout the body including in the brain, spinal cord and heart. Bleeding disorders might occur in the wake of this novel type of Diffused Intravascular Coagulation (DIC) syndrome including profuse bleedings and haemorrhagic stroke.”
Further, “the SARS-CoV-2 spike protein binds to the ACE2 receptor on platelets, which results in their activation. Thrombocytopenia has been reported in severe cases of SARS-CoV-2 infection and in vaccinated individuals.”
They requested evidence that all the above possibilities were excluded in pre-clinical animal models with all three vaccines prior to their approval for use in humans by the EMA.
The approval of the COVID-19 vaccines by the EMA, according to them, was “premature and reckless, and that the administration of the vaccines constitute ‘human experimentation’, which was and still is in violation of the Nuremberg Code”. The Code prohibits human experimentation of the very kind being endorsed and defended by the EMA.
Under these circumstances in Europe, our AEFI monitoring system cannot be so casual about more than 180 deaths in the country. Any death allegedly caused by the COVID-19 vaccine must be thoroughly documented after autopsy and histopathological examination and the results must be made known to the health staff and scientific community.
Science and welfare of humanity must prevail above political mileage. A discerning public will recognise the humility of a responsible caring government in admitting its dilemma based on the adverse events from the field versus wider benefits from mass vaccination. That honesty and transparency on AEFI alone can gain the confidence of the people in taking a calculated risk of continuing with a controversial vaccine. The mist of vaccine hesitancy will melt away quickly by the warm light of truth, if only it is shared.
K.R. Antony is a paediatrician and public health consultant in Kochi